Regulatory changes by the United States government over the past decade have mandated the collection of information known as the Minimum Data Set (“MDS”) for each patient in nursing homes participating in either Medicare or Medicaid programs. The MDS is a standardized assessment instrument consisting of more than 400 items and is used to help identify and quantify a patient's problems, strengths, needs, and preferences so that the patient's quality of life is maintained or enhanced. Assessment items address such areas as activity preferences, indicators of delirium and depression, cognitive functioning, physical functioning, and rehabilitation potential. These data can be of great value to consulting pharmacists and other health care professionals when used for clinical assessment, improvement in clinical practice, and evaluation of outcomes of care.
The MDS is arranged in alphabetic sections. Section “U” of the MDS pertains to patient medications. Information entered in this section includes the names and dosages of all medications ordered within the previous seven days, as-needed drugs such as pain relievers ordered within the past seven days, the method of medicine administration (i.e., oral, intravenous, etc.), frequency of administration, and the amount of medication administered. Unfortunately, most health and human services agencies (such as state-run Medicaid and federally-administered Medicare programs) have not mandated that section “U” information be supplied. As a result, this valuable information is not available for analysis.
Patient-specific medication information combined with patient-specific MDS information is desirable to gather “medical intelligence” regarding a specific patient's care, particularly in the following areas of concern:
Untreated indication—The patient has a medical problem that would benefit from drug therapy but the patient is not receiving medication for that indication.
Improper drug selection—The patient is receiving drug therapy for a medical problem but the medication is not the most effective available.
Subtherapeutic dosage—The patient has medical problem that is being treated with an inadequate dose of the correct medication.
Failure to receive drugs—The patient has a medical problem but is not receiving any medication (e.g., for pharmaceutical, psychological, sociological, or economic reasons).
Overdosage—The patient has a medical problem that is being treated with too much of the correct drug.
Adverse drug reaction—The patient has a medical problem that is the result of an unintended and detrimental adverse drug effect.
Drug interaction—The patient has a medical problem that is the result of a drug-drug, drug-food, or drug-laboratory interaction.
Drug use without indication—The patient is taking a drug without a valid medical reason.
Managed Care Organizations (“MCOs”) and nursing homes are examples of health care organizations that desire this medical intelligence. MCOs work to minimize the cost of health care for their subscribers through a variety of means, including volume purchases, quality control, and negotiated fees. MCOs also have a high level of interest in ensuring that patients receive the proper therapeutics in order to achieve the desired outcome while controlling costs. In particular, nursing homes have an interest in prolonging the lives of their residents by providing quality health care and reducing the medical costs resulting from improper drug therapy.
It is desirable that patient-specific MDS information be collected from nursing homes and that patient-specific medicine information be collected from pharmacies and consulting pharmacies. It is further desired that the information be organized in an electronic format and stored in a data repository. This data must be organized in a manner so as to be compliant with existing and future patient privacy regulations such as those found in the U.S. Health Insurance Portability and Accountability Act (“HIPAA”). In particular, 45 C.F.R. Parts 160 and 164 of the Act relate to standards for privacy of individually identifiable health information (the “Privacy Rule”), promulgated by the Department of Health and Human Services (HHS). In part the privacy rule can restrict the acquisition and use of certain types of patient data, particularly individually identifiable health information. It should be noted that “de-identifying” patient data can entail more than merely redacting the patient's name. This is due to the fact that other patient information such as demographics, medical information, and health care facility information could be used in combination to discern the identity of some patients.
It is also desirable to maximize the use of patient data for gathering patient-specific medical intelligence and for statistical analysis of aggregated data while remaining compliant with applicable patient privacy regulations.
Early methods of directly transferring electronic data from remotely located health care facilities to a data repository have a number of limitations. For example, a data repository that relies on dial-in modems requires many telephone lines to support the input and output needs of multiple data sources and data users. A limited number of telephone lines can create a bottleneck for depositing and extracting data. In addition, depending on the quality of the phone lines, the data transmission rate over the phone lines is often slow, increasing the amount of time required to transfer data and increasing the chances for failed transfers of data. The use of an electronic communication network such as an intranet or the Internet overcomes many of these limitations, making them the medium of choice for multi-site operations. Further, electronic communication networks provide worldwide accessibility and the capability of rapidly transferring data analyses and reports between a large number of locations. However, the open and accessible architecture of many electronic networks such as the Internet makes them a significant security risk. It is undesirable for sensitive patient-related data to be accessed by unauthorized personnel. This can result in the altering or theft of patient data or the dissemination of confidential information to the public or to competitors.
Thus, there is a need for a method to securely accumulate a patient's MDS and drug regimen data, verify it, store it, organize it, and gather medical intelligence by only authorized personnel in a useful format on a timely and secured basis. There is also a need to prevent unauthorized users from altering or viewing the data. There is a further need to provide de-identification of patient data.